An Investigational Drug, Palbociclib (PD-0332991), Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma.
NCT ID: NCT00555906
Last Updated: 2015-03-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
53 participants
INTERVENTIONAL
2008-01-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Bortezomib
Escalating doses of bortezomib will be administered intravenously on Days 8, 11, 15 and 18 of a 28-day cycle (Schedule A) or of a 21-day cycle (Schedule B). The planned doses to be evaluated are 0.7, 1 and 1.3 mg/m2 in combination with PD 0332991 and dexamethasone.
Dexamethasone
20 mg, orally on Days 8, 11, 15 and 18 of a 28 day cycle (Schedule A) or of a 21-day cycle (Schedule B) in combination with PD 0332991 and bortezomib.
PD 0332991
Escalating doses of PD 0332991 will be administered orally on Days 1-21 of a 28-day cycle for Schedule A and on Days 1-12 of a 21-day cycle for Schedule B. The planned doses to be evaluated are 50, 75, 100 mg and 125 mg once daily in combination with bortezomib and dexamethasone.
Interventions
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Bortezomib
Escalating doses of bortezomib will be administered intravenously on Days 8, 11, 15 and 18 of a 28-day cycle (Schedule A) or of a 21-day cycle (Schedule B). The planned doses to be evaluated are 0.7, 1 and 1.3 mg/m2 in combination with PD 0332991 and dexamethasone.
Dexamethasone
20 mg, orally on Days 8, 11, 15 and 18 of a 28 day cycle (Schedule A) or of a 21-day cycle (Schedule B) in combination with PD 0332991 and bortezomib.
PD 0332991
Escalating doses of PD 0332991 will be administered orally on Days 1-21 of a 28-day cycle for Schedule A and on Days 1-12 of a 21-day cycle for Schedule B. The planned doses to be evaluated are 50, 75, 100 mg and 125 mg once daily in combination with bortezomib and dexamethasone.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Phase 1: Relapsed or relapsed/refractory myeloma after at least 1 previous treatments and with a life expectancy of more than 3 months.
* Phase 2: Measurable (as defined by IMWGURC) disease after at least 1 previous treatment.
Exclusion Criteria
* Phase 2 only: Prior bortezomib therapy will only be allowed if there was a demonstrated positive response, and disease progression occurred off therapy.
* Must have not experienced significant blood level changes, e.g. very low platelets, while on previous bortezomib therapy
* Prior radiation therapy to \> 25% of the bone marrow (whole pelvis is 25%).
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Northwestern Medical Faculty Foundation
Chicago, Illinois, United States
Northwestern Memorial Hospital/Main Labs
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, United States
University of Maryland
Baltimore, Maryland, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
New York Presbyterian, Weill Cornell Medical College
New York, New York, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Hollings Cancer Center
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Klinikum Johannes-Gutenberg -Universitaet, III. Medizinische Klinik und Poliklinik
Mainz, , Germany
Countries
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References
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Niesvizky R, Badros AZ, Costa LJ, Ely SA, Singhal SB, Stadtmauer EA, Haideri NA, Yacoub A, Hess G, Lentzsch S, Spicka I, Chanan-Khan AA, Raab MS, Tarantolo S, Vij R, Zonder JA, Huang X, Jayabalan D, Di Liberto M, Huang X, Jiang Y, Kim ST, Randolph S, Chen-Kiang S. Phase 1/2 study of cyclin-dependent kinase (CDK)4/6 inhibitor palbociclib (PD-0332991) with bortezomib and dexamethasone in relapsed/refractory multiple myeloma. Leuk Lymphoma. 2015;56(12):3320-8. doi: 10.3109/10428194.2015.1030641. Epub 2015 May 15.
Related Links
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Other Identifiers
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2010-022515-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A5481004
Identifier Type: -
Identifier Source: org_study_id
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